Allergic Reaction to Contrast MediaPAGE1NCT07268248
1-hour Premedication for Allergy Goal in Emergency: PAGE-1 Study
A study testing IV glucocorticoid and antihistamine in people with Allergic Reaction to Contrast Media and Hypersensitivity Reaction, run by Paul Peng, MD PhD MSCR.
Trial summary
1-hour Premedication for Allergy Goal in Emergency: PAGE-1 is a prospective, parallel, two-arm, non-inferiority, randomized controlled trial evaluating the safety of a 1-hour (intervention) versus a 4-hour (standard regimen) intravenous (IV) premedication protocol in adult patients in the Emergency Department (ED)… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Allergic Reaction to Contrast Media, Hypersensitivity Reaction, Computed Tomography
- What is being tested?
- IV glucocorticoid and antihistamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 21 years old)
- Documented iodinated contrast allergy in the electronic health record
- CT with iodinated contrast ordered for a high-risk indication, † defined as post-arrest, concern for aortic dissection, ischemia, occlusion, obstruction, or other life-threatening conditions requiring timely diagnosis
- Willing and able to give consent
Who cannot join
- Previous enrollment in this study
- Pregnancy
- Seafood or iodine allergy, alone
- Gadolinium allergy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 1-hour Premedication for Allergy Goal in Emergency Computed Tomography, A Randomized Controlled Non-inferiority Trial: PAGE-1 Study
1-hour Premedication for Allergy Goal in Emergency: PAGE-1 is a prospective, parallel, two-arm, non-inferiority, randomized controlled trial evaluating the safety of a 1-hour (intervention) versus a 4-hour (standard regimen) intravenous (IV) premedication protocol in adult patients in the Emergency Department (ED) with a documented iodinated contrast allergy and requiring computed tomography (CT) imaging for a high-risk indication.
Read the detailed description
Allergic or hypersensitivity reactions to iodinated contrast media are rare, estimated to occur in 0.3% to 1.4% of cases, but have decreased significantly after the switch from high-osmolar to low-osmolar contrast. Most reactions are mild, and breakthrough reactions occur regardless of the timing of premedication. IV premedication is recommended, but there is no level I evidence for its basis in the ED.
This study addresses the sparse evidence that underpins the ubiquitous multi-hour premedication protocols in EDs nationwide. It specifically challenges the existing paradigm of 4-5 hours of IV premedication, which has remarkably never been prospectively validated.
- Conditions
- Allergic Reaction to Contrast Media, Hypersensitivity Reaction, Computed Tomography, Premedication
- Being tested
- IV glucocorticoid and antihistamine, IV glucocorticoid and antihistamine (standard of care)
- Keywords
- Iodinated Contrast Reaction, Contrast-enhanced CT, Glucocorticoid prophylaxis
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV glucocorticoid and antihistamineOther
Methylprednisolone sodium succinate (e.g., Solu-Medrol®) 40 mg IV immediately plus diphenhydramine 25 mg IV 1 hour before contrast medium administration for CT imaging
IV glucocorticoid and antihistamine (standard of care)Other
Methylprednisolone sodium succinate (e.g., Solu-Medrol®) 40 mg IV immediately 4 hours before contrast medium administration, plus diphenhydramine 25 mg IV 1 hour before contrast for CT imaging
| Study group | Role | What they receive |
|---|---|---|
| 1-hour Premedication Protocol | Experimental | IV glucocorticoid and antihistamine 1 hour before contrast Receives: Other: IV glucocorticoid and antihistamine |
| 4-hour Premedication Protocol | Active comparator | IV glucocorticoid 4 hours before contrast and IV antihistamine 1 hour before contrast Receives: Other: IV glucocorticoid and antihistamine (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of Acute Contrast Reaction
Measurement of any contrast reaction after contrast administration
Measured: 30 minutes
Proportion of patients eligible for intervention
Ratio of those eligible to screened
Measured: Before randomization
Secondary outcomes (2)
Proportion randomized to intervention and control
Ratio of patients randomized to intervention and control arms, and who complete the protocol as specified
Measured: Within 30 minutes after completion of CT imaging
Adverse events after intervention
Proportion of patients who required intramuscular epinephrine, noninvasive ventilation, or intubation
Measured: Within 30 minutes after assessment of primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Allergic Reaction to Contrast MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Peng, MD PhD MSCR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Peng, MD PhD MSCR, Rutgers, The State University of New Jersey
- Investigators
- Paul Peng, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268248
- Sponsor's protocol ID
- Pro2025002416
- Acronym
- PAGE1
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical plan
Publications
Davenport MS, Cohan RH. The Evidence for and Against Corticosteroid Prophylaxis in At-Risk Patients. Radiol Clin North Am. 2017 Mar;55(2):413-421. doi: 10.1016/j.rcl.2016.10.012.
PubMed 28126223Greenberger PA, Halwig JM, Patterson R, Wallemark CB. Emergency administration of radiocontrast media in high-risk patients. J Allergy Clin Immunol. 1986 Apr;77(4):630-4. doi: 10.1016/0091-6749(86)90357-x.
PubMed 3958391Lasser EC, Berry CC, Talner LB, Santini LC, Lang EK, Gerber FH, Stolberg HO. Pretreatment with corticosteroids to alleviate reactions to intravenous contrast material. N Engl J Med. 1987 Oct 1;317(14):845-9. doi: 10.1056/NEJM198710013171401.
PubMed 3627208Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107.
PubMed 2343107Amiri E. Optimizing Premedication Strategies for Iodinated Contrast Media in CT scans: A Literature Review. J Med Imaging Radiat Sci. 2025 Jan;56(1):101782. doi: 10.1016/j.jmir.2024.101782. Epub 2024 Nov 20.
PubMed 39571411Freed KS, Leder RA, Alexander C, DeLong DM, Kliewer MA. Breakthrough adverse reactions to low-osmolar contrast media after steroid premedication. AJR Am J Roentgenol. 2001 Jun;176(6):1389-92. doi: 10.2214/ajr.176.6.1761389.
PubMed 11373198Mervak BM, Davenport MS, Ellis JH, Cohan RH. Rates of Breakthrough Reactions in Inpatients at High Risk Receiving Premedication Before Contrast-Enhanced CT. AJR Am J Roentgenol. 2015 Jul;205(1):77-84. doi: 10.2214/AJR.14.13810.
PubMed 26102383Mervak BM, Cohan RH, Ellis JH, Khalatbari S, Davenport MS. Intravenous Corticosteroid Premedication Administered 5 Hours before CT Compared with a Traditional 13-Hour Oral Regimen. Radiology. 2017 Nov;285(2):425-433. doi: 10.1148/radiol.2017170107. Epub 2017 Jul 26.
PubMed 28745940Wang CL, Cohan RH, Ellis JH, Caoili EM, Wang G, Francis IR. Frequency, outcome, and appropriateness of treatment of nonionic iodinated contrast media reactions. AJR Am J Roentgenol. 2008 Aug;191(2):409-15. doi: 10.2214/AJR.07.3421.
PubMed 18647910Goldfarb JW. National trends in contrast media enhanced and unenhanced computed tomography use. Clin Imaging. 2023 Jan;93:103-105. doi: 10.1016/j.clinimag.2022.11.009. Epub 2022 Nov 17. No abstract available.
PubMed 36427426Berlyand Y, Fraga JA, Succi MD, Yun BJ, Lee AH, Baugh JJ, Whitehead D, Raja AS, Prabhakar AM. Impact of iodinated contrast allergies on emergency department operations. Am J Emerg Med. 2022 Nov;61:127-130. doi: 10.1016/j.ajem.2022.08.052. Epub 2022 Sep 5.
PubMed 36096014Wang C, Ramsey A, Lang D, Maria Copaescu A, Krishnan P, Kuruvilla M, Mervak B, Newhouse J, Sumkin A, Saff R. Management and Prevention of Hypersensitivity Reactions to Radiocontrast Media: A Consensus Statement from the American College of Radiology and the American Academy of Allergy, Asthma & Immunology. Radiology. 2025 May;315(2):e240100. doi: 10.1148/radiol.240100.
PubMed 40326871